Manager, Regulatory Affairs

Manager - Regulatory Affairs

Responsibilities

• The Regulatory Affairs Manager is responsible for ensuring the successful preparation, submission, and approval of ANDAs as well as post-approval submissions

• This role will guide the regulatory processes for medical drug products, coordinating with internal teams and external agencies to achieve timely approvals

• Lead the preparation, submission, and management of ANDAs

• Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, and Clinical, to gather required documentation and data for submissions

• Liaise with the FDA and other relevant regulatory bodies to ensure submissions are compliant and meet all required standards

• Keep abreast of changes in regulatory guidelines, ensuring that all products under development align with these changes

• Serve as the main contact for regulatory inspections and audits

• Support the implementation of internal regulatory processes and standards

• Help in the creation and maintenance of SOPs related to regulatory submissions

Qualifications

• Demonstrated experience with successful ANDA or NDA approval for one or more drugs

• Minimum 5 years experience with a pharmaceutical company in the Regulatory Affairs department

• In-depth knowledge of FDA regulations and guidelines related to generic drugs

• Strong communication, collaboration, and organizational skills

• Ability to work efficiently in a dynamic, fast-paced environment

• Proficiency in electronic document management systems and tools related to regulatory submissions (eCTD Proficient)

• Project Management experience preferred

• Bachelor’s degree in pharmacy, Biology, Chemistry, or a related field preferred

Job Type: Full-time

Pay: $80,000.00 - $110,000.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Experience:

• Pharmaceutical Companies: 5 years (Preferred)

Ability to Relocate:

• Fort Lauderdale, FL 33304: Relocate before starting work (Required)

Work Location: In person